Actively Recruiting
A Phase 2 Study of Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), CXCR4 Inhibitor (Motixafortide), and Immune Checkpoint Blockade (Cemiplimab) in Treatment-Naive Metastatic Pancreatic Adenocarcinoma
Led by Gulam Manji · Updated on 2025-06-19
10
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
G
Gulam Manji
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for patients with metastatic pancreatic adenocarcinoma who have not received prior therapy. This Phase 2 open-label study aims to assess whether adding motixafortide, a CXCR4 antagonist, to standard chemotherapy (gemcitabine and nab-paclitaxel) and immunotherapy (cemiplimab) can reduce tumor size, extend patient survival, and be safely tolerated. Motixafortide has shown promise in laboratory studies to enhance immunotherapy effects, but its combination with cemiplimab and standard chemotherapy is being tested for the first time in this trial. Participants will first receive motixafortide alone daily for 5 days in a priming phase, followed by motixafortide twice weekly. Cemiplimab is administered intravenously once every 21 days, while gemcitabine and nab-paclitaxel chemotherapy are given intravenously on days 1, 8, and 14 of each 28-day cycle. If serious side effects occur, the treatment plan may be adjusted. The combination uses FDA-approved chemotherapy doses and cemiplimab dosing approved for skin cancer. Participants will be closely monitored throughout the study with assessments of tumor response at 16 weeks using immune-modified RECIST criteria. Researchers will track overall response rate, treatment-related toxicities, progression-free survival, overall survival, duration of clinical benefit, and disease control rate for up to 5 years. Safety evaluations include blood tests, imaging, and biopsies. The study requires informed consent and adherence to protocol, with ongoing follow-up to understand the long-term impact of the combination treatment.
CONDITIONS
Brief Title
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or pathological confirmation of metastatic pancreatic adenocarcinoma
- Cytologic or histologic proof verified by treating pathologist before study therapy
- Pathologic confirmation of unresectable stage IV disease on pretreatment biopsy
- ECOG performance status of 0 or 1
- Age 18 years or older
- Adequate blood counts and organ function within 14 days before treatment
- Measurable disease accessible for fresh biopsy
- Negative pregnancy test for women of childbearing potential and agreement to effective contraception
- Fertile men must agree to use effective birth control with partners
- Ability and willingness to provide written informed consent
- Ability to comply with study protocol
- Negative lower extremity dopplers for deep venous thrombosis or stable anticoagulation if DVT present
- Stable full-dose anticoagulation for at least 2 weeks, with investigator approval for certain clot burdens
You will not qualify if you...
- Prior systemic therapy for pancreatic adenocarcinoma
- Radiation therapy within 2 weeks before study treatment or extensive prior radiation
- Previous surgical resection of pancreatic adenocarcinoma
- Current treatment with other investigational agents
- Unresolved adverse events from prior cancer therapy above specified grades
- Use of other anti-neoplastic agents except hormone therapy
- Uncontrolled pleural, pericardial effusions or ascites
- Uncontrolled tumor-related pain requiring unstable narcotic medication
- History of leptomeningeal or brain/CNS metastases
- Uncontrolled or symptomatic hypercalcemia
- Recent major surgery or significant traumatic injury within 14 days
- Active or history of specified autoimmune diseases or immune deficiency with some exceptions
- History of certain lung diseases or active pneumonitis
- Positive HIV test at or before screening
- Active hepatitis B or C infection
- Significant liver disease
- Active tuberculosis
- Severe infection requiring antibiotics within 2 weeks
- Significant cardiovascular disease within specified time frames
- Low left ventricular ejection fraction or prolonged QTc interval
- Recent severe bleeding events
- Prior stem cell or organ transplantation
- History of other malignancies within 2 years except certain low-risk cancers
- Recent live attenuated vaccinations
- Severe allergic reactions to antibodies or study drug components
- Recent immunosuppressive treatments except certain exceptions
- Pregnancy or breastfeeding
- Uncontrolled psoriasis, porphyria, myopathy, neuropathy
- Severe depression or suicide history
- Recent blood transfusions
- Use of corticosteroids above specified doses except as allowed per guidelines
- Any other condition deemed unsafe or affecting study interpretation by investigator
- Uncontrolled skin or neurological conditions as specified
- Hospitalization for depression within 2 years or prior suicide attempts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 days
Participants receive 5 days of daily motixafortide injections to prime before starting combination treatment.
5 daily visits (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive motixafortide twice weekly, cemiplimab once every three weeks, and chemotherapy with gemcitabine and nab-paclitaxel on days 1, 8, and 14 of each 28-day cycle.
Twice weekly visits for motixafortide injections, cemiplimab every 3 weeks, and chemotherapy on days 1, 8, and 14 each cycle
Trial Site Locations
Total: 3 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
2
Brown University
Providence, Rhode Island, United States, 02912
Actively Recruiting
3
Medical College of Wisconsin, Wisconsin Diagnostic Labratories
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Research Nurse Navigator
G
Gulam Manji, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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